21 CFR 1309.21 - Persons required to register.

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§ 1309.21 Persons required to register.
(a) Unless exempted by law or under §§ 1309.24 through 1309.26 or §§ 1310.12 through 1310.13 of this chapter, the following persons must annually obtain a registration specific to the List I chemicals to be handled:
(1) Every person who manufactures or imports or proposes to manufacture or import a List I chemical or a drug product containing ephedrine, pseudoephedrine, or phenylpropanolamine.
(2) Every person who distributes or exports or proposes to distribute or export any List I chemical, other than those List I chemicals contained in a product exempted under paragraph (1)(iv) of the definition of regulated transaction in § 1300.02 of this chapter.
(b) Only persons actually engaged in the activities are required to obtain a registration; related or affiliated persons who are not engaged in the activities are not required to be registered. (For example, a stockholder or parent corporation of a corporation distributing List I chemicals is not required to obtain a registration.)
(c) The registration requirements are summarized in the following table:
Summary of Registration Requirements and Limitations
Businessactivity Chemicals DEA Forms Application fee Registration period(years) Coincident activities allowed
Manufacturing List I New-510 $3,047 1 May distribute that chemical for which registration was issued; may not distribute any chemical for which not registered.
Drug products containing ephedrine, pseudoephedrine, phenylpropanolamine Renewal-510a 3,047
Distributing List I New-510 1,523 1
Scheduled listed chemical products Renewal-510a 1,523
Importing List I New-510 1,523 1 May distribute that chemical for which registration was issued; may not distribute any chemical for which not registered.
Drug Products containing ephedrine, pseudoephedrine, phenylpropanolamine Renewal-510a 1,523
Exporting List I New-510 1,523 1
Scheduled listed chemical products Renewal-510a 1,523
[75 FR 4980, Feb. 1, 2010, as amended at 77 FR 4236, Jan. 27, 2012; 77 FR 15250, Mar. 15, 2012]

Title 21 published on 2013-04-01

no entries appear in the Federal Register after this date.